The following data is part of a premarket notification filed by Uresil Corp. with the FDA for Uresil Thora-flo Thoracentesis Procedure Kit.
Device ID | K872948 |
510k Number | K872948 |
Device Name: | URESIL THORA-FLO THORACENTESIS PROCEDURE KIT |
Classification | Catheter And Tip, Suction |
Applicant | URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
Contact | Michael Jaron |
Correspondent | Michael Jaron URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
Product Code | JOL |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent - With Drug (SESD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-28 |
Decision Date | 1987-11-27 |